Senior Director, CMC Regulatory Affairs
Mineralys Therapeutics(10 days ago)
About this role
Mineralys Therapeutics is a fully remote, clinical-stage biopharmaceutical company focusing on developing medicines for hypertension and related conditions. They are seeking a Senior Director, CMC Regulatory to lead their global CMC regulatory strategies, submissions, and cross-functional collaborations, supporting the development and lifecycle management of their products.
Required Skills
- CMC
- Regulatory Strategy
- Regulatory Submissions
- Global Compliance
- FDA
- EMA
- ICH Guidelines
- Quality Systems
- Lifecycle Management
- Cross-Functional Collaboration
About Mineralys Therapeutics
mineralystx.comMineralys Therapeutics is a biotech company focused on developing targeted approaches to control hypertension. The company works on precision therapies designed to address underlying physiological drivers of high blood pressure with the goal of improving efficacy and tolerability compared with standard treatments. Mineralys advances a pipeline of investigational candidates through preclinical and clinical development and partners with academic and industry collaborators to accelerate translation. Their mission is to deliver durable, patient-centered blood pressure control for people inadequately managed by current therapies.
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